Metastatic MedulloblastomaPhase 2NCT01542736

Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)

A Phase 2 study testing Carboplatin, Vincristine and 24 Gy in people with Metastatic Medulloblastoma and High Risk Supratentorial PNET, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and… Read more about this study

Who is it for?: Ages 3 to 25 years
Conditions the study is for: Metastatic Medulloblastoma, High Risk Supratentorial PNET, Metastatic PNET
What is being tested?: Carboplatin, Vincristine and 24 Gy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: May 2007to Sep 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age greater than 3 years and less than 25 years
Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI.
Patients with high-risk supratentorial, non-metastatic, PNET
Patients with metastatic PNET
Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision
Only patients who are expected to survive at least 6 weeks will be eligible for this study.

Who cannot join

Patients who are pregnant may not be treated on this study
Patients with anaplastic histology

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital Colorado
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET

Conditions: Metastatic Medulloblastoma, High Risk Supratentorial PNET, Metastatic PNET
Being tested: Carboplatin, Vincristine, 24 Gy
Medical subject headings: Medulloblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarboplatinDrug
Administered concurrently with craniospinal radiation.
VincristineDrug
Administered concurrently with craniospinal radiation.
24 GyRadiation
Craniospinal radiation.

Study groups in NCT01542736
Study group	Role	What they receive
Reduced radiation with concurrent chemotherapy	Experimental	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Receives: Drug: Carboplatin; Drug: Vincristine; Radiation: 24 Gy

What is being measured

The primary outcome is the main question the study is designed to answer.

Event-free Survival
MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Measured: Up to 60 months.
Overall Survival
Overall Survival will be measured at the end of study. number of surviving participants is reported.
Measured: up to 5 years
Intellectual Competence Measured by IQ Score: Week 8
Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Measured: Week 8
Intellectual Competence Measured by IQ Score: Month 24
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Measured: Month 24
Intellectual Competence Measured by IQ Score: Month 60
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Measured: Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Sep 2020

First posted2 Mar 2012 (estimated)
Study startMay 2007
Primary completionSep 2020
Study completionSep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic MedulloblastomaStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01542736
Sponsor's protocol ID: 06-1151
Status last verified: Dec 2021
First submitted: 27 Feb 2012
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
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Active, not recruitingPhase 1
Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma
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All Metastatic Medulloblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET
ClinicalTrials.gov ID: NCT01542736
Acronym / sponsor ID: 06-1151
Conditions: Metastatic Medulloblastoma, High Risk Supratentorial PNET, Metastatic PNET
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: May 2007
Primary completion: Sep 2020 (actual)
Study completion: Sep 2020 (actual)
First posted: 2 Mar 2012 (estimated)
Results: Posted 11 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Reduced radiation with concurrent chemotherapy	Experimental	Drug: Carboplatin, Drug: Vincristine, Radiation: 24 GyReduced dose craniospinal radiation with concurrent carboplatin and vincristine administration

Who may qualify

Ages: 3 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Age greater than 3 years and less than 25 years
Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI.
Patients with high-risk supratentorial, non-metastatic, PNET
Patients with metastatic PNET
Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision

Key exclusion criteria (2 listed)

Patients who are pregnant may not be treated on this study
Patients with anaplastic histology

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CarboplatinAdministered concurrently with craniospinal radiation.	Drug	Reduced radiation with concurrent chemotherapy
VincristineAdministered concurrently with craniospinal radiation.	Drug	Reduced radiation with concurrent chemotherapy
24 GyCraniospinal radiation.	Radiation	Reduced radiation with concurrent chemotherapy

Primary outcome

Event-free Survival
Time frame: Up to 60 months.
MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Overall Survival
Time frame: up to 5 years
Overall Survival will be measured at the end of study. number of surviving participants is reported.
Intellectual Competence Measured by IQ Score: Week 8
Time frame: Week 8
Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Intellectual Competence Measured by IQ Score: Month 24
Time frame: Month 24
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Intellectual Competence Measured by IQ Score: Month 60
Time frame: Month 60
Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

Results and safety

Results posted to the registry on 11 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reduced Radiation With Concurrent Chemotherapy	8	7

Primary outcome: Event-free Survival

Time frame: Up to 60 months.. Count of participants. Unit: Participants

Measure	Reduced Radiation With Concurrent Chemotherapy n = 8
Value	7

Primary outcome: Overall Survival

Time frame: up to 5 years. Count of participants. Unit: Participants

Measure	Reduced Radiation With Concurrent Chemotherapy n = 8
Value	7

Primary outcome: Intellectual Competence Measured by IQ Score: Week 8

Time frame: Week 8. Mean (Full Range). Unit: score on a scale

Measure	Reduced Radiation With Concurrent Chemotherapy n = 5
Value	102.4 (84 to 122)

Population analysed: Not all participants were feeling well enough to complete testing at this timepoint.

Primary outcome: Intellectual Competence Measured by IQ Score: Month 24

Time frame: Month 24. Mean (Full Range). Unit: score on a scale

Measure	Reduced Radiation With Concurrent Chemotherapy n = 6
Value	96.83 (80 to 127)

Population analysed: Not all participants were feeling well enough to complete testing at this timepoint.

Adverse events

Time frame: Until time of death or progression (Up to 10 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reduced Radiation With Concurrent Chemotherapy	1 of 8 (12.5%)	1 of 8 (12.5%)	1 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Medulloblastoma

RecruitingPhase 1
A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
Recurrent Medulloblastoma, Refractory Medulloblastoma
Active, not recruitingPhase 1/2
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
Solid Tumors, CNS Tumors
RecruitingPhase 1
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
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RecruitingPhase 1
Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Madden, RN, CPNP principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free Survival (time frame: Up to 60 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.